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Kapidex side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Kapidex: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

chest pain, fast or pounding heartbeats;

severe stomach pain; or

worsening heartburn.

Less serious Kapidex side effects may include:

nausea, vomiting, stomach pain, gas;

diarrhea; or stuffy nose, sneezing, or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Some side effects of Kapidex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dexlansoprazole: oral capsule delayed releaseAlong with its needed effects, dexlansoprazole (the active ingredient contained in Kapidex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.Check with your doctor immediately if any of the following side effects occur while taking dexlansoprazole:Less common

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach cramps

stomach discomfort, fullness, upset, or pain

sweating

swelling

swelling of the eyelids, face, lips, hands, or feet

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tenderness in the stomach area

thirst

troubled breathing with exertion

uncomfortable swelling around the anus

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

watery or bloody diarrhea

weight loss

wheezing

yellow eyes or skin

Incidence not known

Drowsiness

muscle spasms (tetany) or twitching

seizures

trembling

Some side effects of dexlansoprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common

Abnormal dreams

blemishes on the skin

blistering, crusting, irritation, itching, or reddening of the skin

body aches or pain

bumps on the skin

burning or itching around the anus

burning while urinating

change in taste or bad, unusual, or unpleasant (after) taste

changes in appetite

changes in menstrual periods

chills

congestion

continuing ringing or buzzing or other unexplained noise in the ears

cough

cracked, dry, or scaly skin

decreased interest in sexual intercourse

decreased sexual ability in males

difficult or painful urination

difficulty with moving

dry, puffy skin

ear congestion

ear pain

excess air or gas in the stomach or intestines

falls

feeling cold

feeling of constant movement of self or surroundings

feeling of warmth

frequent strong or increased urge to urinate

general feeling of discomfort or illness

hearing loss

heavy bleeding

hiccups

hives or welts

inability to have or keep an erection

lack or loss of strength

longer or heavier menstrual periods

loss in sexual ability, desire, drive, or performance

loss of voice

muscle or bone pain

muscle stiffness

noisy breathing

pain around the anus

pain or tenderness around the eyes and cheekbones

pain, swelling, or redness in the joints

painful sexual intercourse

pimples

red, sore eyes

redness of the face, neck, arms, and occasionally, upper chest

sensation of spinning

shivering

sleeplessness

sneezing

sore throat

stuffy or runny nose

sudden sweating

sunburn

thick, white, or curd-like vaginal discharge

trouble remembering

trouble sleeping

unable to sleep

voice changes

weight gain

GastrointestinalGastrointestinal side effects have included diarrhea (4.7% to 5.1%), abdominal pain (3.5% to 4%), nausea (2.8% to 3.3%), vomiting (1.4% to 2.2%), and flatulence (1.4% to 2.6%). Other gastrointestinal side effects reported in clinical studies at an incidence of less than 2% were abnormal feces, anal discomfort, Barrett’s esophagus, bezoar, abnormal bowel sounds, breath odor, microscopic colitis, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, mucus stools, oral mucosal blistering, painful defecation, proctitis, oral paresthesia, and rectal hemorrhage.The most common adverse reaction leading to discontinuation of dexlansoprazole in clinical studies was diarrhea (0.7%).RespiratoryRespiratory side effects have included upper respiratory tract infection (1.7% to 2.9%). Other respiratory side effects reported in clinical studies at an incidence of less than 2% were aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, respiratory tract congestion, and sore throat.MusculoskeletalMusculoskeletal side effects reported in clinical studies at an incidence of less than 2% were arthralgia, arthritis, muscle cramps, musculoskeletal pain, bursitis, and myalgia. Postmarketing studies have shown an increased risk of bone fracture.MetabolicMetabolic side effects reported in clinical studies at an incidence of less than 2% were appetite changes, hypercalcemia, hypokalemia, dehydration, diabetes mellitus, hyperglycemia, hyperlipidemia, and weight increase. FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches, and spasm of the voice box.CardiovascularCardiovascular side effects reported in clinical studies at an incidence of less than 2% were angina, arrhythmia, bradycardia, tachycardia, chest pain, edema, myocardial infarction, palpitation, hypertension, and vertigo.Nervous systemNervous system side effects reported in clinical studies at an incidence of less than 2% were convulsion, dizziness, headaches, migraine, paresthesia, psychomotor hyperactivity, tremor, pain, chills, pyrexia, auditory hallucination, trigeminal neuralgia, restless legs syndrome, and somnolence.RenalRenal system side effects reported in clinical studies at an incidence of less than 2% were dysuria and micturition urgency.PsychiatricPsychiatric system side effects reported in clinical studies at an incidence of less than 2% were abnormal dreams, anxiety, depression, insomnia, memory impairment, and libido changes.EndocrineEndocrine system side effects reported in clinical studies at an incidence of less than 2% were dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder, hot flushes, hypothyroidism, gout, lymphadenopathy, and goiter.OcularOcular system side effects reported in clinical studies at an incidence of less than 2% were eye irritation and eye swelling.HematologicHematologic system side effects reported in clinical studies at an incidence of less than 2% were anemia, epistaxis, neutropenia, thrombocythemia, increased neutrophils, MCHC decrease, and deep vein thrombosis.ImmunologicImmunologic system side effects reported in clinical studies at an incidence of less than 2% were candida infections, influenza, pharyngitis, nasopharyngitis, oral herpes, sinusitis, viral infection, herpes zoster, and vulvovaginal infection. Postmarketing immunologic system side effects have included anaphylactic shock (requiring emergency intervention), Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal).HepaticHepatic system side effects reported in clinical studies at an incidence of less than 2% were biliary colic, cholelithiasis, and hepatomegaly.DermatologicDermatologic side effects reported in clinical studies at an incidence of less than 2% were acne, dermatitis, erythema, pruritus, rash, skin lesion, and urticaria.GeneralGeneral side effects reported in clinical studies at an incidence of less than 2% were ear pain, tinnitus, asthenia, chills, mucosal inflammation, nodule, sunburn, dysphonia, folliculitis, tonsillitis, altered taste, oral soft tissue disorder, and feeling abnormal.OtherOther side effects reported in clinical studies at an incidence of less than 2% were ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, liver function test abnormal, platelet count decreased, and total protein increased.

Drugs & Medications – Kapidex Oral

KAPIDEX ORAL USES

Dexlansoprazole is used to treat certain stomach and esophagus problems (such asacid reflux). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Dexlansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.Dexlansoprazole may also be used to treat stomach ulcers.How to use Kapidex oralRead the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking dexlansoprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once daily with or without food. If your symptoms usually occur after a meal, your doctor may direct you to take your dose every day before the same meal for best results. Dosage and length of treatment are based on your medical condition and response to treatment.Do not crush or chew the capsules. Swallow this medication whole. If you have trouble swallowing this medication whole, you may open the capsule and sprinkle the contents onto 1 tablespoon (15 milliliters) of applesauce. Swallow all of the drug/food mixture right away without chewing it. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug.If you are giving this drug with a liquid medication measuring device/syringe, or through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take dexlansoprazole at least 30 minutes before sucralfate.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.Tell your doctor if your condition persists or worsens.

Kapidex Delayed Release Capsules

Kapidex (dexlansoprazole delayed release capsules) is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid). It decreases the amount of acid produced in the stomach. Common side effects include nausea, vomiting, stomach pain, gas, diarrhea, or stuffy nose, sneezing, or other cold symptoms.The recommended adult dose of Kapidex is 30 mg or 60 mg, taken once daily as directed. Kapidex may interact with ampicillin, atazanavir, clopidogrel, digoxin, ketoconazole, blood thinners, or iron. Tell your doctor all medications and supplements you use. Kapidex is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.Our Kapidex (dexlansoprazole delayed release capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

SIDE EFFECTS

Clinical Trials Experience

The safety of KAPIDEX (dexlansoprazole delayed release capsules) was evaluated in 4548 patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least 6 months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% other races. Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on KAPIDEX (dexlansoprazole delayed release capsules) 30 mg, 2218 patients on KAPIDEX (dexlansoprazole delayed release capsules) 60 mg, and 1363 patients on lansoprazole 30 mg once daily.As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Most Commonly Reported Adverse Reactions

Adverse Reactions Resulting in Discontinuation

In controlled clinical studies, the most common adverse reaction leading to discontinuation from KAPIDEX (dexlansoprazole delayed release capsules) therapy was diarrhea (0.7%).

Kapidex sideeffects

Get emergency medical help if you have any of these signs of an allergic reaction to Kapidex: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

chest pain, fast or pounding heartbeats;

severe stomachpain; or

worsening heartburn.

Less serious Kapidexside effects may include:

nausea, vomiting, stomach pain, gas;

diarrhea; or stuffy nose, sneezing, or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Some sideeffects of Kapidex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dexlansoprazole: oral capsule delayed releaseAlong with its needed effects, dexlansoprazole (the active ingredient contained in Kapidex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.Check with your doctor immediately if any of the following side effects occur while taking dexlansoprazole:Less common

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach cramps

stomach discomfort, fullness, upset, or pain

sweating

swelling

swelling of the eyelids, face, lips, hands, or feet

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tenderness in the stomach area

thirst

troubled breathing with exertion

uncomfortable swelling around the anus

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

watery or bloody diarrhea

weight loss

wheezing

yellow eyes or skin

Incidence not known

Drowsiness

muscle spasms (tetany) or twitching

seizures

trembling

Some side effects of dexlansoprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these sideeffects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common

Abnormal dreams

blemishes on the skin

blistering, crusting, irritation, itching, or reddening of the skin

body aches or pain

bumps on the skin

burning or itching around the anus

burning while urinating

change in taste or bad, unusual, or unpleasant (after) taste

changes in appetite

changes in menstrual periods

chills

congestion

continuing ringing or buzzing or other unexplained noise in the ears

cough

cracked, dry, or scaly skin

decreased interest in sexual intercourse

decreased sexual ability in males

difficult or painful urination

difficulty with moving

dry, puffy skin

ear congestion

ear pain

excess air or gas in the stomach or intestines

falls

feeling cold

feeling of constant movement of self or surroundings

feeling of warmth

frequent strong or increased urge to urinate

general feeling of discomfort or illness

hearing loss

heavy bleeding

hiccups

hives or welts

inability to have or keep an erection

lack or loss of strength

longer or heavier menstrual periods

loss in sexual ability, desire, drive, or performance

loss of voice

muscle or bone pain

muscle stiffness

noisy breathing

pain around the anus

pain or tenderness around the eyes and cheekbones

pain, swelling, or redness in the joints

painful sexual intercourse

pimples

red, sore eyes

redness of the face, neck, arms, and occasionally, upper chest

sensation of spinning

shivering

sleeplessness

sneezing

sore throat

stuffy or runny nose

sudden sweating

sunburn

thick, white, or curd-like vaginal discharge

trouble remembering

trouble sleeping

unable to sleep

voice changes

weight gain

GastrointestinalGastrointestinal sideeffects have included diarrhea (4.7% to 5.1%), abdominal pain (3.5% to 4%), nausea (2.8% to 3.3%), vomiting (1.4% to 2.2%), and flatulence (1.4% to 2.6%). Other gastrointestinal side effects reported in clinical studies at an incidence of less than 2% were abnormal feces, anal discomfort, Barrett’s esophagus, bezoar, abnormal bowel sounds, breath odor, microscopic colitis, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, mucus stools, oral mucosal blistering, painful defecation, proctitis, oral paresthesia, and rectal hemorrhage.The most common adverse reaction leading to discontinuation of dexlansoprazole in clinical studies was diarrhea (0.7%).RespiratoryRespiratory side effects have included upper respiratory tract infection (1.7% to 2.9%). Other respiratory side effects reported in clinical studies at an incidence of less than 2% were aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, respiratory tract congestion, and sore throat.MusculoskeletalMusculoskeletal side effects reported in clinical studies at an incidence of less than 2% were arthralgia, arthritis, muscle cramps, musculoskeletal pain, bursitis, and myalgia. Postmarketing studies have shown an increased risk of bone fracture.MetabolicMetabolic side effects reported in clinical studies at an incidence of less than 2% were appetite changes, hypercalcemia, hypokalemia, dehydration, diabetes mellitus, hyperglycemia, hyperlipidemia, and weight increase. FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches, and spasm of the voice box.CardiovascularCardiovascular side effects reported in clinical studies at an incidence of less than 2% were angina, arrhythmia, bradycardia, tachycardia, chest pain, edema, myocardial infarction, palpitation, hypertension, and vertigo.Nervous systemNervous system side effects reported in clinical studies at an incidence of less than 2% were convulsion, dizziness, headaches, migraine, paresthesia, psychomotor hyperactivity, tremor, pain, chills, pyrexia, auditory hallucination, trigeminal neuralgia, restless legs syndrome, and somnolence.RenalRenal system side effects reported in clinical studies at an incidence of less than 2% were dysuria and micturition urgency.PsychiatricPsychiatric system side effects reported in clinical studies at an incidence of less than 2% were abnormal dreams, anxiety, depression, insomnia, memory impairment, and libido changes.EndocrineEndocrine system side effects reported in clinical studies at an incidence of less than 2% were dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder, hot flushes, hypothyroidism, gout, lymphadenopathy, and goiter.OcularOcular system side effects reported in clinical studies at an incidence of less than 2% were eye irritation and eye swelling.HematologicHematologic system side effects reported in clinical studies at an incidence of less than 2% were anemia, epistaxis, neutropenia, thrombocythemia, increased neutrophils, MCHC decrease, and deep vein thrombosis.ImmunologicImmunologic system side effects reported in clinical studies at an incidence of less than 2% were candida infections, influenza, pharyngitis, nasopharyngitis, oral herpes, sinusitis, viral infection, herpes zoster, and vulvovaginal infection. Postmarketing immunologic system side effects have included anaphylactic shock (requiring emergency intervention), Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal).HepaticHepatic system side effects reported in clinical studies at an incidence of less than 2% were biliary colic, cholelithiasis, and hepatomegaly.DermatologicDermatologic side effects reported in clinical studies at an incidence of less than 2% were acne, dermatitis, erythema, pruritus, rash, skin lesion, and urticaria.GeneralGeneral side effects reported in clinical studies at an incidence of less than 2% were ear pain, tinnitus, asthenia, chills, mucosal inflammation, nodule, sunburn, dysphonia, folliculitis, tonsillitis, altered taste, oral soft tissue disorder, and feeling abnormal.OtherOther side effects reported in clinical studies at an incidence of less than 2% were ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, liver function test abnormal, platelet count decreased, and total protein increased.

Drugs & Medications – Kapidex Oral

KAPIDEX ORAL USES

Dexlansoprazole is used to treat certain stomach and esophagus problems (such asacid reflux). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Dexlansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.Dexlansoprazole may also be used to treat stomach ulcers.How to use Kapidex oralRead the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking dexlansoprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once daily with or without food. If your symptoms usually occur after a meal, your doctor may direct you to take your dose every day before the same meal for best results. Dosage and length of treatment are based on your medical condition and response to treatment.Do not crush or chew the capsules. Swallow this medication whole. If you have trouble swallowing this medication whole, you may open the capsule and sprinkle the contents onto 1 tablespoon (15 milliliters) of applesauce. Swallow all of the drug/food mixture right away without chewing it. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug.If you are giving this drug with a liquid medication measuring device/syringe, or through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take dexlansoprazole at least 30 minutes before sucralfate.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.Tell your doctor if your condition persists or worsens.

Kapidex Delayed Release Capsules

Kapidex (dexlansoprazole delayed release capsules) is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid). It decreases the amount of acid produced in the stomach. Common side effects include nausea, vomiting, stomach pain, gas, diarrhea, or stuffy nose, sneezing, or other cold symptoms.The recommended adult dose of Kapidex is 30 mg or 60 mg, taken once daily as directed. Kapidex may interact with ampicillin, atazanavir, clopidogrel, digoxin, ketoconazole, blood thinners, or iron. Tell your doctor all medications and supplements you use. Kapidex is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.Our Kapidex (dexlansoprazole delayed release capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential sideeffects when taking this medication.

SIDE EFFECTS

Clinical Trials Experience

The safety of KAPIDEX (dexlansoprazole delayed release capsules) was evaluated in 4548 patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least 6 months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% other races. Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on KAPIDEX (dexlansoprazole delayed release capsules) 30 mg, 2218 patients on KAPIDEX (dexlansoprazole delayed release capsules) 60 mg, and 1363 patients on lansoprazole 30 mg once daily.As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Most Commonly Reported Adverse Reactions

Adverse Reactions Resulting in Discontinuation

In controlled clinical studies, the most common adverse reaction leading to discontinuation from KAPIDEX (dexlansoprazole delayed release capsules) therapy was diarrhea (0.7%).